An mHealth Intervention to Improve HIV Prevention Service Engagement Among People Who Use Drugs
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LOTUS mHealth Intervention Group.
- Who it may be relevant to
- Registry conditions: HIV Infections. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
LOTUS: An mHealth Intervention to Improve HIV Prevention Service Engagement Among People Who Use Drugs
Overview
The goal of this single arm pre-post study is to assess the feasibility, acceptability, and preliminary impact of the LOTUS intervention to improve HIV prevention service engagement among people who use drugs. LOTUS is a technology-delivered intervention that provides HIV prevention informational content and tips, peer social support and social networking features, a resource locator, HIV prevention monitoring and reminders (e.g., reminders for HIV/STI testing and PrEP doses), and a virtual space to have questions answered by health care professionals.
Detailed description
The LOTUS intervention is a technology-delivered intervention to improve HIV prevention service engagement for people who use drugs. LOTUS provides HIV prevention informational content and tips, peer social support and social networking features, a resource locator, HIV prevention monitoring and reminders (e.g., reminders for HIV/STI testing and PrEP doses), and a virtual space to have questions answered by health care professionals. Given the disproportionate HIV-related harms people who use drugs face, and critical need for HIV prevention mHealth interventions tailored to the unique needs of this population, the current study seeks to accomplish the following aim. The primary aim is to assess the feasibility, acceptability, and preliminary impact of the LOTUS intervention in a single arm pre-post study. People who use drugs residing in Southern California (n = 40) will receive the LOTUS intervention for 6-months. The proportion of participants retained, intervention use data, and validated self-reported usability and HIV prevention service (e.g., HIV/STI testing, PrEP) knowledge, motivation, and use measures will be collected at baseline, 3-, and 6-months to assess LOTUS feasibility, acceptability, and preliminary impact. The investigators hypothesize that participants in the LOTUS intervention will find the intervention to be feasible and usable, and that they will demonstrate significant improvements in HIV prevention service use at each follow-up time point when compared to baseline. The investigators will also conduct exit interviews with LOTUS participants (n = 20) to gain feedback on the intervention characteristics, as defined by the Consolidated Framework for Implementation Research, and to elicit suggestions for improvement in anticipation of a future large-scale randomized controlled trial.
Interventions
- Behavioral LOTUS mHealth Intervention Group
A mobile, WebApp-based intervention comprised of tips for HIV prevention, a community wall for peer interaction and support, HIV prevention monitoring and reminders, a virtual space to have questions answered by a healthcare professional, a resource database, and a personalized profile. Intervention components are designed to promote HIV prevention service use and improve social support, coping strategies, and positive affect.
Primary outcome measures
- LOTUS Feasibility [Time frame: 6 months]
- LOTUS Acceptability [Time frame: 6 months]
- HIV Prevention Service Engagement [Time frame: 6 months]
Secondary outcome measures (1)
- Attitudes and Perceptions [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- 18 years of age or older
- Report weekly or daily use of opioids and/or stimulants in the past 6 months
- Meet current CDC eligibility criteria for PrEP
- Report low levels of HIV prevention service engagement in the past 6 months
- Not currently, or planning on becoming, pregnant during the study
- Owns a smartphone with internet web-browsing capabilities
Exclusion criteria
- 17 years of age or younger
- Does not report weekly or daily use of opioids and/or stimulants in the past 6 months
- Does not meet current CDC eligibility criteria for PrEP
- Report high levels of HIV prevention service engagement in the past 6 months
- Currently, or planning on becoming, pregnant during the study
- Does not own a smartphone with internet web-browsing capabilities
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- University of California San Diego — La Jolla
Identifiers
NCT: NCT06068283 · 310548-00001 · K01DA055983